Combination Therapy of Microwave Ablation and Cellular Immunotherapy for Hepatocellular Carcinoma

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorChinese PLA General Hospital

About this trial

The study is to observe safety, survival effect and peripheral T-lymphocyte subsets of combination therapy with percutaneous microwave ablation (MWA) and adoptive immunotherapy in hepatocellular carcinoma(HCC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

single HCC of 5 cm or smaller;

three or fewer multiple HCC with a maximum dimension of 3 cm or less;

absence of portal vein thrombosis or extrahepatic metastases;

Child-Pugh classification A or B;

Disqualifiers

pregnant or breast-feeding; psychiatric problems, addiction, or any other disorder that prevented informed consent;

active uncontrolled infection; concurrent systemic corticosteroid treatment;

systemic autoimmune disease;

clinically significant ischemic heart disease or cardiac failure;

Trial design

Design model

Parallel

Treatments tested in this trial

  • adoptive immunotherapy

    Biological/Vaccine

    Patients with HCC (tumor diameter ≤5 cm and fewer than three tumors) underwent radical MWA followed by cellular immunotherapy. In the CIK-based cohort, patients received 4-6 courses annually, starting at 2, 4, 6, 10, 14, and 18 weeks after MWA, followed by treatment every 12 weeks. Peripheral blood mononuclear cells were differentiated into phenotypically confirmed DCs and effector cells. DC-CIK and CTL were administered intraperitoneally, and CIK cells were infused intravenously. In the NK-cell cohort, patients received six NK-cell infusions at 2-week intervals after complete MWA and normalization of body temperature. NK cells were expanded ex vivo from autologous peripheral blood, allogeneic peripheral blood, or umbilical cord blood.

  • MWA

    Procedure/Surgery

    ALL the HCC patients will be treated only by microwave ablation and then enter the follow-up

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: MWA onlyActive comparator 1 intervention
Group B: MWA combined with immunotherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Cumulative survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and combination treatment will be done by the log-rank test.

Time frame
up to 8 years

Secondary outcomes

1

disease free survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and combination treatment will be done by the log-rank test

Time frame
up to 8 years

Other outcomes

1

Local tumor progress rates were calculated by the Kaplan-Meier method, and comparison between MWA and combination treatment will be done by the log-rank test

Time frame
up to 8 years

Sponsors and contacts

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